Data On Fosamax Fail To Support Long Term Use

In earlier issues, we initially reported osteonecrosis of the jaw (“ONJ”) (sudden death of jaw bone) being caused by long-term use of Fosamax. Then, in 2010 we wrote about the atypical subtrochanteric (femur) fractures being reported from long-term use of use of bisphosphonates like Fosamax. Both of these injuries are significant and almost unheard of in non-cancer patients absent bisphosphonate use.

In the course of pretrial discovery of the ONJ cases, analysis conducted by FDA reviewers of the benefit of long-term use of bisphosphonates was discovered. The conclusion of the FDA reviewer was that women received no added benefit of taking Fosamax for more than three to five years. Interestingly, that is when the risk of developing ONJ and subtrochanteric fractures begins to increase significantly. Earlier this year the FDA required manufacturers to warn on their labels that an optimal duration of use had not been established. FDA reviewers, however, concluded:

In light of the potential risks that may be associated with long-term use of bisphosphonates for the treatment and/or prevention of osteoporosis, the sum of available long-term efficacy data appears to suggest that bisphosphonate therapy could be safely discontinued for some period of time,

The Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee recently held a joint meeting to address these growing concerns as well as the increasing data regarding a link between bisphosphonates and esophageal cancer. After reviewing the data the Committees avoided providing any specific guidance to the FDA, but did vote (17 to 6) that the FDA should “further clarify the duration of use” of the drugs. A new label is expected to be released in November. Hopefully, science will prevail over marketing and the drug’s use will be restricted to no more than five years. If you need more information on Fosamax, contact Russ Abney or Chad Cook, lawyers in our Mass Torts Section, at 800-898-2034 or by email at Russ.Abney@beasleyallen.com or Chad.Cook@beasleyallen.com.